Pharmacist Guided Pre-emptive Pharmacogenetic Testing in Antidepressant Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 190
- Locations
- 4
- Primary Endpoint
- rate of response to the antidepressant therapy at the end of week 4
Study Overview
Brief Summary
In this study at the Solothurn Psychiatric Clinic, the investigators compare the effectiveness and tolerability of antidepressant pharmacotherapy in three groups. In the intervention group, the physician selects and doses the medication for depression based on a pharmacogenetic examination conducted by a clinical pharmacist. In the standard group, the treating physician selects and doses the antidepressant drug without the support of genetic testing, in accordance with current standard practice. If after the first week of hopsitalization no adjustment to a new antidepressant is necessary, the investigators will monitor the progress of these patients until they leave the clinic in an observational arm. The drugs used are all approved in Switzerland for the treatment of depression. Classification into the intervention or standard group is made randomly after the first week of hospitalisation, if the treating physician deems it necessary to change or readjust the antidepressant pharmacotherapy. The probability of allocation to one of the two study groups is 50%. All study participants will be hospitalized for at least five weeks and monitored until they leave the clinic. In total, it is planned to include and examine 95 patients each into the intervention and standard group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 18 years old
- •Diagnosis unipolar moderate or severe depressive episode or recurrent depressive disorder (ICD10: F32.1/32.2/33.1/33.2)
- •HAM-D17 ≥ 17
Exclusion Criteria
- •Acute suicide risk
- •Psychotic symptomatology
- •Other acute serious psychiatric disorder other than depression
- •Excessive consumption of alcohol and/or drugs
- •Severe acute - or severe chronic somatic diseases
- •Pregnant / lactating women
- •Under current treatment with fluoxetine
Arms & Interventions
Intervention
Intervention: Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing (Procedure)
Standard Care
Intervention: Standard care antidepressant selection and dosing (Procedure)
Observational
Outcomes
Primary Outcomes
rate of response to the antidepressant therapy at the end of week 4
Time Frame: 28 days
response is determined as a reduction in the Hamilton Depression (HAM-D17) Scale score of at least 50 % of the baseline value
Secondary Outcomes
- Number of adverse events related to antidepressant pharmacotherapy(28 days)
- Patient depression self-rating(28 days)
- Remission rate(28 days)
- Overall change in 17 item Hamilton rating scale for Depression (HAM-D17) from baseline to week 4(28 days)
- Side effect measure (self-rated frequency, intensity and burden of side effects, FIBSER score)(28 days)
- Time to response(28 days)
- Time till discharge(assessed up to 3 month)
Investigators
PD Dr. med. Thorsten Mikoteit
Deputy Head Physician Division Psychiatry
University of Basel